Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice

Multi-centre, patient- and observer-blinded, two-armed, parallel groups randomised controlled trial. 7 French University hospital will include 350 patients presenting with AAA or aorto iliac occlusive disease suitable for endovascular treatment, to either repair using standard X-ray fluoroscopy imaging alone (the current reference standard) or augmented with automated image fusion. The study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system.

The trial will be conducted in 7 centres in France over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. Every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included.

Radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.

Inclusion criteria

• Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with no image fusion available
• Surgeon trained in the use of image fusion
• Operator who has given their consent
• Endovascular management of an aorto-iliac artery disease or a sub-renal AAA using a sub-renal bifurcated stent graft
• Patient in possession of an angioscan less than 6 months old
• Patient of legal age who has given his/her consent
• Ionising radiation generator with up-to-date and validated quality control
• Participant affiliated to a Social Security scheme

Exclusion criteria

• First procedure with fusion for the previously trained surgeon.
• Procedure performed without an operating aid.
• Emergency procedure.
• Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch).

digestive arteries, iliac branch).

• Patients with AAA that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft)
• Aortic emergencies (ruptured AAA).
• Persons under guardianship, curatorship or safeguard of justice
• Pregnant or breast-feeding women.